BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB

    MDR report key: 9172102 · Received October 9, 2019

    Report

    Report Number
    8041187-2019-00800
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    September 18, 2019
    Report Date
    November 12, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE REPRESENTATIVE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, THERE WERE NO DEFORMATION OR DAMAGED OBSERVED ON THE ECLIPSE HUB AND SAFETY SHIELD AND THERE WAS NO BREAKAGE OBSERVED ON THE SAFETY LOCK PIN. ADDITIONAL TESTING (HUB HOOK BREAKAGE, SAFETY SHIELD FALL OFF/BREAK OFF, AND ACTIVATION/LOCKING FORCE) WERE PERFORMED AND ALL SAMPLES PASSED INSPECTION. BASED ON THE VISUAL INSPECTION AND TESTING THE REPORTED FAILURE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MATERIAL NO.: 305787 , BATCH NO.: 8082132. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB THE SAFETY MECHANISM BENT TO THE SIDE RESULTING IN A NEEDLE STICK TO THE USER. BLOOD WORK WAS DONE TO TEST FOR BLOODBORNE PATHOGENS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT HAPPENED IN ROOM 6 IN OUR OFFICE. USER WAS WEARING GLOVES AS PPE. THE USER ADMINISTERED A FLU VACCINE TO THE PATIENT. USER ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM OF THE SYRINGE. INSTEAD OF CLOSING THE NEEDLE, THE SAFETY MECHANISM TURNED TO THE SIDE RESULTING TO A PUNCTURE ON THE USER'S LEFT PALM.

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: K980987(SYRINGE); K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 305787 BATCH NO.: 8082132. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB THE SAFETY MECHANISM BENT TO THE SIDE RESULTING IN A NEEDLE STICK TO THE USER. BLOOD WORK WAS DONE TO TEST FOR BLOODBORNE PATHOGENS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT HAPPENED IN ROOM 6 IN OUR OFFICE. USER WAS WEARING GLOVES AS PPE. THE USER ADMINISTERED A FLU VACCINE TO THE PATIENT. USER ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM OF THE SYRINGE. INSTEAD OF CLOSING THE NEEDLE, THE SAFETY MECHANISM TURNED TO THE SIDE RESULTING TO A PUNCTURE ON THE USER'S LEFT PALM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967833 SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8082132 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention